Comparison of effectiveness of epidural analgesia and monitored anesthesia care for high-intensity focused ultrasound treatment of adenomyosis

Figures & data

Table 1. Inclusion and exclusion criteria for HIFU treatment of adenomyosis.

Inclusion criteria

Adult women over 20 years old Before or during the menopause (follicle-stimulating hormone <40 mIU/mL) Uterine adenomyosis was clinically diagnosed with MR or US evaluation. Dysmenorrhea score ≥4/5 (a great deal symptom) No other treatment on the adenomyosis within 3 months before the HIFU treatment (Hormonal treatment cessation during more than 5 times of the drug  half-life even within 3 months) Voluntary agreement on the clinical trial and willing to obey the trial plan. Agreement on the medically-permitted contraception if the participant is fertile.

Exclusion criteria

Any other pelvic disease – malignancy, endometriosis, ovarian tumour, acute pelvic disease, etc. Clinically suspected sarcoma Diffuse adenomyosis Pregnancy or hope to be pregnant Critical systemic condition Hematocrit <25% Wide abdominal scar in the path of ultrasound beam, which is not overcome with scar patch Surgical scar or clip in the path of HIFU beam Supine position is impossible. Contraindication of MRI (including claustrophobia) Contraindication of MRI contrast media Contraindication of ultrasound contrast media Glomerular filtration rate <30 mL/min Communication is impossible. Subject who enrolled into other clinical trials within a month Subject who the investigator excluded because of any other reason

HIFU: High-intensity focused ultrasound.

Figure 1. Serial images of epidural catheterisation. The tip of a 17G Tuohy needle was in the epidural space (a), epidural catheter with curved steel wire (white arrows) was advanced cephalad (b), and 3 ml of contrast media was injected (c). There is no evidence of vascular uptake or subdural spreading pattern.

Table 2. Demographic and clinical data of the study population.

	EA group (n = 31)	MAC group (n = 37)	p-value
Age (years)	43.0 [41.0, 45.0]	44.0 [41.5, 45.5]	.616
Body mass index (kg/m^2)	22.3 ± 2.6	23.2 ± 3.2	.247
Abdominal wall thickness (cm)	2.2 ± 0.7	2.4 ± 0.7	.388
Preexisting postoperative scar in the lower abdomen	3 (9.7%)	13 (35.1%)	.014
Location of adenomyosis
Anterior	7 (22.6%)	7 (18.9%)	.515
Posterior	17 (54.8%)	18 (48.6%)
Antero-posterior	4 (12.9%)	10 (27.0%)
Fundus	3 (9.7%)	2 (5.4%)
Volume of adenomyosis (cm^3)	70.8 [45.6, 152.6]	81.5 [39.7, 145.5]	.868

Data are reported as the mean ± standard deviation or median [first interquartile, third interquartile] or number (%) of patients.

EA: epidural analgesia; MAC: monitored anesthesia care.

Figure 2. The proportion of intraprocedural pain intensity during HIFU treatment in the MAC group (n = 37) and the EA group (n = 31). The pain intensity was reported using a 6-point Likert scale (0, no pain; 1, mild pain; 2, mild-moderate pain; 3, moderate pain; 4, severe pain; 5, very severe pain).

Table 3. Clinical outcomes of epidural analgesia and patient-controlled epidural analgesia for HIFU treatment.

	EA group (n = 31)	MAC group (n = 37)	p-value
Severe or very severe intraoperative pain	13 (41.9%)	28 (75.7%)	.006
Procedure time (minutes)	91.2 ± 28.9	98.7 ± 33.9	.338
IV analgesics and sedative usage
Remifentanil (µg)	173 ± 189	426 ± 380	.001
Incidence of Midazolam Injection	0 (0.0%)	6 (16.2%)	.028
Fentanyl (µg)	52 ± 38	75 ± 44	.030
NPV ratio	0.87 ± 0.18	0.43 ± 0.32	<.001
Incidence of acute postprocedural pain	12 (38.7%)	24 (64.9%)	.031
Rescue analgesics	6 (19.4%)	13 (35.1%)	.149
Acetaminophen	2 (6.5%)	7 (18.9%)
Acetaminophen + Tramadol	1 (3.2%)	0 (0.0%)
Acetaminophen + NSAID + Codeine	0 (0.0%)	1 (2.7%)
NSAIDs	3 (9.7%)	5 (13.5%)

Data are reported as the mean ± standard deviation or number (%) of patients.

EA: epidural analgesia; HIFU: High-intensity focused ultrasound; IV: intravenous; MAC: monitored anesthesia care; NSAID: non-steroidal anti-inflammatory drug; NPV: non-perfused volume.

Table 4. Multivariable analysis between the NPV ratio and Clinical Variables.

	Univariable Analysis		Multivariable Analysis
	B (95% CI)	p-value	B (95% CI)	β	p-value
Age (per 10 years)	0.06 (−0.15, 0.27)	.589
Abdominal wall thickness	−0.09 (−0.20, 0.03)	.144
Scar in lower abdomen	−0.05 (−0.24, 0.15)	.638
Location of Adenomyosis
Anterior	Reference
Posterior	−0.06 (−0.27, 0.15)	.597
Antero-posterior	−0.25 (−0.50, 0.00)	.048	−0.22 (−0.38, −0.07)	−0.27	.006
Fundus	0.18 (−0.17, 0.52)	.306
Volume of adenomyosis (per 100 mL)	0.06 (−0.01, 0.12)	.113	0.08 (0.03, 0.14)	0.29	.002
Epidural analgesia	0.44 (0.31, 0.57)	<.001	0.41 (0.29, 0.53)	0.60	<.001

Stepwise selection was conducted to remain significant variables (p values < .05).

B: non-standardized coefficient; β: standardized coefficient; NPV: non-perfused volume.

Table 5. Adverse Events (AEs), Adjuvant Drug Usage, and Complications.

	EA group (n = 31)	MAC group (n = 37)	p-value
AEs before the HIFU treatment
Tingling sensation or warm sensation in the lower extremities, above knee*	10 (32.3%)	0 (0.0%)	<.001
AEs during the HIFU treatment	9 (29.0%)	14 (37.8%)	.445
Nausea/Vomiting
Adjuvant drug usage
Dexamethasone	0 (0.0%)	14 (37.8%)	<.001
Tingling sensation newly developed in the lower extremities	0 (0.0%)	3 (8.1%)	.245
Dizziness	2 (6.5%)	0 (0.0%)	.204
Headache	1 (3.2%)	0 (0.0%)	.456
Shivering	1 (3.2%)	0 (0.0%)	.456
Hypertension	0 (0.0%)	1 (2.7%)	1.000
AEs in the recovery room
5-HT3 blocker use due to nausea/vomiting	8 (25.8%)	23 (62.2%)	.003
Voiding difficulty in the recovery room*	7 (22.6%)	0 (0.0%)	.003
Continuing tingling sensation remained at discharge	2 (6.5%)	2 (5.5%)	1.000
AEs after discharge
Disconnection or pump failure*	2 (6.5%)	0 (0.0%)	.204
Catheter site local inflammation*	1 (3.2%)	0 (0.0%)	.456
Thermal injury associated with the HIFU
treatment	24 (77.4%)	17 (45.9%)
None	7 (22.6%)	20 (54.1%)	.00
Positive	5 (16.1%)	16 (43.2%)	8
Mild	1 (3.2%)	3 (8.1%)
Moderate	1 (3.2%)	1 (2.7%)
Severe**

* Adverse events may occur in association with epidural analgesia.

** One severe thermal injury in the EA group was gluteal burn which needed surgical flap operation and the other severe thermal injury in the MAC group was proctitis which required hospitalization for a week.

AE: adverse event; EA: epidural analgesia; MAC: monitored anesthesia care.